Recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT06010251

Conditions

Spinal Cord Injuries

Neuropathic Pain

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

tDCS and bodily illusions

Study Details

Brief summary:

The purpose of this study is to investigate the effectiveness of bodily illusions combined with transcranial direct current stimulation (tDCS) on neuropathic pain symptoms and sensory functions in participants with spinal cord injury (SCI) and neuropathic pain.

Conditions

Spinal Cord Injuries

Neuropathic Pain

Study ID

NCT06010251

Start date

Oct 17, 2023

Status verified date

Nov, 2025

Completion date

Oct 20, 2026

Anticipated

Primary completion date

Oct 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

The study will be open to people of any ethnicity, racial background, and gender.

Inclusion criteria:

SCI with Pain:

1. Men or women
2. fluent in English
3. 18-70 years of age who have: (3a) Complete and incomplete SCI, level of injury (above L1); (3b) Persistent neuropathic pain started after the injury for a minimum of three months prior to entering the study that is at least moderate in severity, defined as ≥ 4 on a Numeric Rating Scale (NRS) ranging 0 to 10.

Exclusion criteria:

Participants will be excluded if they have:

1. Major psychiatric disease/disorder (self-reported);
2. a significant neurological trauma (self-reported) other than SCI;
3. a recent (one-year) history of alcohol or drug abuse assessed by the Drug Abuse Screening Test (DAST-10)
4. history of visual and hearing loss not corrected
5. history of epilepsy or seizures
6. any metal implants in the head, or implanted devices such as cochlea implants or cardiac pacemakers.

We will not include any special population like:

Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SCI with pain

Participants will undergo 2-4 weeks of combined intervention including transcranial direct current stimulation (tDCS) and bodily illusions (10 sessions total).

Interventions

tDCS and bodily illusions

Participants will be required to perform (in person) 10 interventions over a time frame of 2-4 weeks. They can perform this everyday or for a minimum of 2-3 times per week over 4 weeks.

Two types of illusions will be used 15 min each, the rubber hand illusion and the walking illusion to target upper and lower limbs. These procedures will impact the body representation of the participants resulting in bodily illusions.

Primary outcome measure

  • Change in neuropathic pain severity assessed by Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Baseline, up to 4 weeks ]
  • Change in neuropathic pain interference assessed by pain interference questionnaire. [ Time Frame: Baseline, up to 4 weeks ]
  • Changes associated with sensory function/dysfunction assessed by quantitative sensory testing [ Time Frame: Baseline, up to 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Principal Investigator:

Eva Widerstrom-Noga, PhD

More Information

Sponsor

University of Miami

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2025-11-21.